Recalls / Class II
Class IID-0565-2016
Product
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
- Affected lot / code info
- Lot # 151379 and Lot #151380; Exp 12/16
Why it was recalled
Presence of Particulate Matter
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 2,784 cartons (278,400 capsules)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-10-29
- FDA classified
- 2016-01-08
- Posted by FDA
- 2016-01-20
- Terminated
- 2017-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0565-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.